FDA wedged between a rock and a hard place in DTC debate

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There's a scene in the film "And Justice For All" in which Al Pacino, as attorney Arthur Kirkland, delivers this blast to a legal committee: "In theory, what this committee is trying to do is admirable. In practice, however, it sucks."

That about sums up the efforts of the Food and Drug Administration to resolve the thorny issues surrounding direct-to-consumer pharmaceutical advertising.

In theory, what the FDA is trying to do is admirable-satisfy supporters of a $4 billion industry while at the same time address the concerns of DTC opponents. In practice, however, it sucks-for the FDA, which is caught between a rock and a hard place, the rock being the First Amendment right to free speech and the hard place its own (under)staffing issues.

Despite the best intentions of the federal agency in holding two-day public hearings last week, gamely subjecting itself to the rhetoric of 39 speakers who alternately conjured up the merits and evils of DTC, the prospect of meaningful change in the category seems unrealistic.

Marketers such as Bristol-Myers Squibb and Pfizer have already instituted self-imposed mandates such as a moratorium on ads until a drug has been on the market for a certain amount of time. But if the public hearings made anything abundantly clear, it's that the FDA has little ability to make an impact either way.

Dueling ideas

For every speaker who presented survey results showing a growing percentage of patients prompted by DTC ads to see their doctors, another produced a study that claimed "no empirical research has demonstrated better communication between patients and physicians and improved health outcomes."

Every outlandish idea from one side-such as a total ban on DTC-was met with an equally improbable one from the other. Witness Astra-Zeneca's proposal to support mandatory FDA review of DTC advertisements (the process is voluntary right now) but only if the agency's Division of Drug Marketing, Advertising and Communications has the necessary resources to conduct its review within a specific time frame. That's laughable because the FDA's staffing woes are well known within the industry. The DDMAC unit has 40 staffers who last year reviewed 52,800 pieces of drug promotions, including commercials, print ads, fliers and more. That's nearly double the 31,600 pieces reviewed in all categories in 1999.

The FDA also lacks the ability to easily make wholesale changes to DTC advertising. John Kamp, director of the Coalition for Healthcare Communication, said that any effort by the agency to impose a moratorium on advertising would be met with a court challenge on First Amendment grounds.

Small changes

Any changes are likely to come in small increments, such as clarifications of the presentation of risk/benefit information and tweaks of ad messaging to address critics' concerns. During one presentation, Duke University researcher Ruth Day showed a clip of a BBDO commercial for Nasonex allergy spray featuring the voice of Antonio Banderas as an animated bee. Ms. Day pointed out that when side effects were discussed, the bee's wings flapped rapidly, perhaps distracting viewers, but when benefits were talked about, the bee's wings were stationary. (Nasonex marketer Schering-Plough Corp. said only that "the intent of the spot is to provide a memorable character" to alert allergy sufferers to "an effective treatment option.")

When Pfizer President of U.S. Pharmaceuticals J. Patrick Kelly said that "high priority" diseases such as asthma and diabetes would take more of a toll on public health if left untreated, Dr. Robert Temple, director of the FDA's Office of Medical Policy, suggested Pfizer could tailor its messages to help address the problem.

For now, such polite prompts may be the best the FDA can do.

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